Mobile insulin dosing tool gets FDA clearance

The US Food and Drug Administration has OK'd a mobile system meant to help people with type 2 diabetes more easily measure and adjust insulin.

Glooko's Mobile Insulin Dosing System can access a patient's blood glucose data from a glucose meter.

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Glooko's Mobile Insulin Dosing System (MIDS) was cleared Wednesday for the titration of long-acting insulin. The system can directly access a patient's blood glucose data from a glucose meter, cutting the need to manually enter fasting blood glucose levels. Health care providers can also access more-accurate diabetes data with the system, and are able to create and send custom treatment plans via Glooko's unified diabetes management app, the company said.

MIDS evaluates fasting blood glucose levels and recommends changes to insulin dosage, based on the health provider's treatment plan or published clinical guidelines. In-app reminders notify patients to take insulin and to check fasting blood glucose.

"Managing long-acting insulin can be a challenge for people with diabetes because it requires patients to regularly change their doses based on their own calculations using fasting glucose values," Dr. Michael Greenfield, chief medical officer at Glooko, said in a statement. "This can be daunting and unreliable."

Glooko spent 18 months conducting research and collecting feedback to ensure the system was market-ready, it said in a statement. A study involving 14 participants found that MIDS helped people with diabetes manage their insulin and glycemic control over a span of one to three weeks. Positive outcomes were associated with titration cycle adherence. A larger clinical trial is also underway.

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